ID

39400

Description

EVAHEART LVAS Bridge-to-Transplant Pivotal Study; ODM derived from: https://clinicaltrials.gov/show/NCT01187368

Link

https://clinicaltrials.gov/show/NCT01187368

Keywords

Versions (1)
  1. 1/7/20 1/7/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 7, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01187368

English

Eligibility Heart Failure NCT01187368

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
the following is a list of general inclusion criteria:
Description

Inclusion criteria General

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0205246
age ≥ 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
listed for cardiac transplant as a status 1a or 1b
Description

Patient on waiting list Heart Transplantation | Waiting list status

Data type

boolean

Alias
UMLS CUI [1,1]
C0422768
UMLS CUI [1,2]
C0018823
UMLS CUI [2]
C0586018
nyha class iv heart failure
Description

Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
patient is able to provide written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
more detailed inclusion criteria information is noted in the study protocol
Description

Inclusion criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C2348563
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
the following is a list of general exclusion criteria:
Description

Exclusion Criteria General

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0205246
active, uncontrolled infection
Description

Communicable Disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
bsa < 1.4 m²
Description

Body Surface Area

Data type

boolean

Alias
UMLS CUI [1]
C0005902
irreversible organ failure
Description

Organ failure

Data type

boolean

Alias
UMLS CUI [1]
C0349410
severe right ventricular failure
Description

Right ventricular failure Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C2939447
UMLS CUI [1,2]
C0205082
prosthetic mechanical aortic or mitral valve
Description

Mechanical Aortic Valve | Mechanical Mitral Valve

Data type

boolean

Alias
UMLS CUI [1]
C2825203
UMLS CUI [2]
C2825205
patients with an unacceptable risk for successful lvad implantation and maintenance
Description

Implantation of left ventricular assist device At risk | Left ventricular assist device Maintenance At risk

Data type

boolean

Alias
UMLS CUI [1,1]
C0397130
UMLS CUI [1,2]
C1444641
UMLS CUI [2,1]
C0181598
UMLS CUI [2,2]
C0024501
UMLS CUI [2,3]
C1444641
patients refusing blood transfusion
Description

Transfusion blood refusal

Data type

boolean

Alias
UMLS CUI [1]
C0749628
intolerant of anticoagulation therapy
Description

Intolerant Anticoagulation Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0231200
UMLS CUI [1,2]
C0003281
coagulopathy
Description

Blood Coagulation Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0005779
active psychiatric disorder, irreversible cognitive dysfunction or other psychosocial behavior that impairs the ability of the patient to follow instructions, maintain their device or their medical regimen
Description

Mental disorder Impairing Protocol Compliance | Cognitive dysfunction Impairing Protocol Compliance | Psychosocial Factors Impairing Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0338656
UMLS CUI [2,2]
C0221099
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C0033963
UMLS CUI [3,2]
C0221099
UMLS CUI [3,3]
C0525058
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
current dependence on other mechanical circulatory support device at the time of implant, other than iabp
Description

Patient need for Mechanical Circulatory Support Device | Exception Intra-Aortic Balloon Pump

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C3274791
UMLS CUI [1,3]
C0025080
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0021860
presence of condition other than heart failure that would limit survival to less than 3 years
Description

Condition Limiting Survival | Exception Heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0038952
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018801
more detailed exclusion criteria information is noted in the study protocol
Description

Exclusion Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Heart Failure NCT01187368

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion criteria General
Item
the following is a list of general inclusion criteria:
boolean
C1512693 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Patient on waiting list Heart Transplantation | Waiting list status
Item
listed for cardiac transplant as a status 1a or 1b
boolean
C0422768 (UMLS CUI [1,1])
C0018823 (UMLS CUI [1,2])
C0586018 (UMLS CUI [2])
Heart failure New York Heart Association Classification
Item
nyha class iv heart failure
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Informed Consent
Item
patient is able to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Inclusion criteria Study Protocol
Item
more detailed inclusion criteria information is noted in the study protocol
boolean
C1512693 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria General
Item
the following is a list of general exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
Communicable Disease Uncontrolled
Item
active, uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Body Surface Area
Item
bsa < 1.4 m²
boolean
C0005902 (UMLS CUI [1])
Organ failure
Item
irreversible organ failure
boolean
C0349410 (UMLS CUI [1])
Right ventricular failure Severe
Item
severe right ventricular failure
boolean
C2939447 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Mechanical Aortic Valve | Mechanical Mitral Valve
Item
prosthetic mechanical aortic or mitral valve
boolean
C2825203 (UMLS CUI [1])
C2825205 (UMLS CUI [2])
Implantation of left ventricular assist device At risk | Left ventricular assist device Maintenance At risk
Item
patients with an unacceptable risk for successful lvad implantation and maintenance
boolean
C0397130 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0181598 (UMLS CUI [2,1])
C0024501 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
Transfusion blood refusal
Item
patients refusing blood transfusion
boolean
C0749628 (UMLS CUI [1])
Intolerant Anticoagulation Therapy
Item
intolerant of anticoagulation therapy
boolean
C0231200 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
Blood Coagulation Disorder
Item
coagulopathy
boolean
C0005779 (UMLS CUI [1])
Mental disorder Impairing Protocol Compliance | Cognitive dysfunction Impairing Protocol Compliance | Psychosocial Factors Impairing Protocol Compliance
Item
active psychiatric disorder, irreversible cognitive dysfunction or other psychosocial behavior that impairs the ability of the patient to follow instructions, maintain their device or their medical regimen
boolean
C0004936 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0338656 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0033963 (UMLS CUI [3,1])
C0221099 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Patient need for Mechanical Circulatory Support Device | Exception Intra-Aortic Balloon Pump
Item
current dependence on other mechanical circulatory support device at the time of implant, other than iabp
boolean
C0686904 (UMLS CUI [1,1])
C3274791 (UMLS CUI [1,2])
C0025080 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0021860 (UMLS CUI [2,2])
Condition Limiting Survival | Exception Heart failure
Item
presence of condition other than heart failure that would limit survival to less than 3 years
boolean
C0348080 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0038952 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0018801 (UMLS CUI [2,2])
Exclusion Criteria Study Protocol
Item
more detailed exclusion criteria information is noted in the study protocol
boolean
C0680251 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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